Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive
Status:
Completed
Trial end date:
2020-04-09
Target enrollment:
Participant gender:
Summary
Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains
high. If anticoagulation is perfectly codified, the remainder of the initial management has
been less studied.
In particular, the "conditioning" Initial often involves systematic plasma volume of 250 to
500 cc, by analogy to other situations. But this treatment option is not based on factual
data. In the right ventricular dysfunction that often accompany severe EP, volume expansion
may instead be harmful, according to the law of Frank Starling. A retrospective study has
recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive
EP.
The proposed study is interventional, prospective, multicenter, randomized, require to
include 60 patients.
The main objective of the study is the comparison of the troponin normalization period Ic
(biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of
a serious normotensive EP, between the 2 groups diuretic and filling Vascular.
The primary endpoint is the time in hours standardization of troponin Ic.
The secondary endpoints will be:
- the period of normalization of Brain Natriuretic Peptide (BNP)
- changes in echocardiographic parameters of right ventricular dysfunction
- a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of
thrombolysis.